REZUM
Report
- Report Number
- 2124215-2025-44595
- Event Type
- Injury
- Date Received
- July 7, 2025
- Date of Event
- June 1, 2020
- Report Date
- April 9, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LO, K. L., MOK, A., KO, I. C. H., YUEN, S. K. K., CHIU, P. K. F., & NG, C. F. (2024). TRANSURETHRAL WATER VAPOUR THERMAL THERAPY FOR BENIGN PROSTATIC HYPERPLASIA UNDER LOCAL ANAESTHESIA ALONE: INITIAL EXPERIENCE IN CHINESE PATIENTS. HONG KONG MEDICAL JOURNAL. XIANGGANG YI XUE ZA ZHI, 30(3), 227-232. HTTPS://DOI.ORG/10.12809/HKMJ2210330. THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS ARE A KNOWN RISK ASSOCIATED WITH THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.
AFTER FURTHER REVIEW IT WAS DEEMED THAT THIS EVENT IS A DUPLICATE EVENT OF (B)(4), THIS EVENT WAS REPORTED UNDER (B)(4). DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LO, K. L., MOK, A., KO, I. C. H., YUEN, S. K. K., CHIU, P. K. F., & NG, C. F. (2024). TRANSURETHRAL WATER VAPOUR THERMAL THERAPY FOR BENIGN PROSTATIC HYPERPLASIA UNDER LOCAL ANAESTHESIA ALONE: INITIAL EXPERIENCE IN CHINESE PATIENTS. HONG KONG MEDICAL JOURNAL. XIANGGANG YI XUE ZA ZHI, 30(3), 227-232. HTTPS://DOI.ORG/10.12809/HKMJ2210330.
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LO, K. L., MOK, A., KO, I. C. H., YUEN, S. K. K., CHIU, P. K. F., & NG, C. F. (2024). TRANSURETHRAL WATER VAPOUR THERMAL THERAPY FOR BENIGN PROSTATIC HYPERPLASIA UNDER LOCAL ANAESTHESIA ALONE: INITIAL EXPERIENCE IN CHINESE PATIENTS. HONG KONG MEDICAL JOURNAL. XIANGGANG YI XUE ZA ZHI, 30(3), 227-232. HTTPS://DOI.ORG/10.12809/HKMJ2210330.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE HONG KONG MEDICAL JOURNAL THAT A RETROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE PERIOPERATIVE AND EARLY POSTOPERATIVE OUTCOMES OF TRANSURETHRAL WATER VAPOR THERMAL THERAPY (WVTT) UNDER LOCAL ANESTHESIA ALONE FOR BENIGN PROSTATIC ENLARGEMENT IN CHINESE PATIENTS. A TOTAL OF 50 CHINESE PATIENTS WHO EXHIBITED CLINICAL INDICATIONS (ACUTE RETENTION OF URINE OR SYMPTOMATIC LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC ENLARGEMENT) FOR SURGICAL TREATMENT BETWEEN JUNE 2020 AND DECEMBER 2021 IN HONG KONG WERE INCLUDED. EXCLUSION CRITERIA INCLUDED ACTIVE URINARY TRACT PROBLEMS AND UROLOGICAL MALIGNANCIES. FOLLOW-UP WAS CONDUCTED AT 3 MONTHS POSTOPERATIVELY. THE MEDIAN PATIENT AGE WAS 71.5 YEARS. THE MEAN PREOPERATIVE PROSTATIC VOLUME WAS 56.7 ML. THE MEAN OPERATION TIME WAS 25.1 MINUTES. ALL PROCEDURES WERE PERFORMED UNDER LOCAL ANESTHESIA ALONE. THE MEAN PAIN SCORES FOR TRANSRECTAL ULTRASOUND PROBE INSERTION, TRANSPERINEAL LOCAL ANESTHESIA INJECTION, AND TRANSURETHRAL WVTT WERE 2, 5, AND 4, RESPECTIVELY. FORTY-NINE PATIENTS (98%) WERE DISCHARGED ON THE SAME DAY WITH A URETHRAL CATHETER. FORTY-EIGHT PATIENTS (96%) SUCCESSFULLY COMPLETED A TRIAL WITHOUT CATHETER WITHIN 3 WEEKS POSTOPERATIVELY. FIVE PATIENTS (10%) HAD UNPLANNED HOSPITAL ADMISSION WITHIN 30 DAYS POSTOPERATIVELY DUE TO SURGICAL COMPLICATIONS (CLAVIEN-DINDO GRADE 1). ONLY ONE PATIENT (2%) REQUIRED BLADDER IRRIGATION FOR 5 DAYS POSTOPERATIVELY; THAT PATIENT HAD BEEN TAKING APIXABAN BEFORE SURGERY. TWO PATIENTS (4%) WITH AN INITIALLY UNSUCCESSFUL TWOC BEGAN TEMPORARY CLEAN INTERMITTENT SELF-CATHETERISATION; THEY WERE SUBSEQUENTLY WEANED FROM THIS MANAGEMENT APPROACH ON POSTOPERATIVE DAYS 40 AND 45, RESPECTIVELY. THERE WERE THREE REPORTED CASES (6%) OF NEW-ONSET ERECTILE DYSFUNCTION POSTOPERATIVELY. ALL THREE PATIENTS HAD TEMPORARY ERECTILE DYSFUNCTION THAT RESOLVED WITHIN 6 MONTHS POSTOPERATIVELY WITHOUT REQUIRING MEDICATION. SOME ADDITIONAL ADVERSE EVENTS OBSERVED IN THE STUDY WERE LIGHT HEMATURIA, POST-OBSTRUCTIVE DIURESIS, RECURRENT ACUTE RETENTION OF URINE (AROU) AND URINARY TRACT INFECTION (UTI) WITH AROU. TRANSURETHRAL WVTT, AN ADVANCED SURGICAL TREATMENT FOR BENIGN PROSTATIC ENLARGEMENT, IS A SAFE PROCEDURE THAT RELIEVES LOWER URINARY TRACT SYMPTOMS WITH MINIMAL HOSPITAL STAY. IT CAN BE PERFORMED IN AN OFFICE-BASED SETTING UNDER LOCAL ANESTHESIA, MAXIMIZING UTILIZATION OF THE SURGICAL THEATRE.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE HONG KONG MEDICAL JOURNAL THAT A RETROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE PERIOPERATIVE AND EARLY POSTOPERATIVE OUTCOMES OF TRANSURETHRAL WATER VAPOR THERMAL THERAPY (WVTT) UNDER LOCAL ANESTHESIA ALONE FOR BENIGN PROSTATIC ENLARGEMENT IN CHINESE PATIENTS. A TOTAL OF 50 CHINESE PATIENTS WHO EXHIBITED CLINICAL INDICATIONS (ACUTE RETENTION OF URINE OR SYMPTOMATIC LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC ENLARGEMENT) FOR SURGICAL TREATMENT BETWEEN JUNE 2020 AND DECEMBER 2021 IN HONG KONG WERE INCLUDED. EXCLUSION CRITERIA INCLUDED ACTIVE URINARY TRACT PROBLEMS AND UROLOGICAL MALIGNANCIES. FOLLOW-UP WAS CONDUCTED AT 3 MONTHS POSTOPERATIVELY. THE MEDIAN PATIENT AGE WAS 71.5 YEARS. THE MEAN PREOPERATIVE PROSTATIC VOLUME WAS 56.7 ML. THE MEAN OPERATION TIME WAS 25.1 MINUTES. ALL PROCEDURES WERE PERFORMED UNDER LOCAL ANESTHESIA ALONE. THE MEAN PAIN SCORES FOR TRANSRECTAL ULTRASOUND PROBE INSERTION, TRANSPERINEAL LOCAL ANESTHESIA INJECTION, AND TRANSURETHRAL WVTT WERE 2, 5, AND 4, RESPECTIVELY. FORTY-NINE PATIENTS (98%) WERE DISCHARGED ON THE SAME DAY WITH A URETHRAL CATHETER. FORTY-EIGHT PATIENTS (96%) SUCCESSFULLY COMPLETED A TRIAL WITHOUT CATHETER WITHIN 3 WEEKS POSTOPERATIVELY. FIVE PATIENTS (10%) HAD UNPLANNED HOSPITAL ADMISSION WITHIN 30 DAYS POSTOPERATIVELY DUE TO SURGICAL COMPLICATIONS CLAVIEN-DINDO GRADE 1. ONLY ONE PATIENT (2%) REQUIRED BLADDER IRRIGATION FOR 5 DAYS POSTOPERATIVELY; THAT PATIENT HAD BEEN TAKING APIXABAN BEFORE SURGERY. TWO PATIENTS (4%) WITH AN INITIALLY UNSUCCESSFUL TWOC BEGAN TEMPORARY CLEAN INTERMITTENT SELF-CATHETERISATION; THEY WERE SUBSEQUENTLY WEANED FROM THIS MANAGEMENT APPROACH ON POSTOPERATIVE DAYS 40 AND 45, RESPECTIVELY. THERE WERE THREE REPORTED CASES (6%) OF NEW-ONSET ERECTILE DYSFUNCTION POSTOPERATIVELY. ALL THREE PATIENTS HAD TEMPORARY ERECTILE DYSFUNCTION THAT RESOLVED WITHIN 6 MONTHS POSTOPERATIVELY WITHOUT REQUIRING MEDICATION. SOME ADDITIONAL ADVERSE EVENTS OBSERVED IN THE STUDY WERE LIGHT HEMATURIA, POST-OBSTRUCTIVE DIURESIS, RECURRENT ACUTE RETENTION OF URINE (AROU) AND URINARY TRACT INFECTION (UTI) WITH AROU. TRANSURETHRAL WVTT, AN ADVANCED SURGICAL TREATMENT FOR BENIGN PROSTATIC ENLARGEMENT, IS A SAFE PROCEDURE THAT RELIEVES LOWER URINARY TRACT SYMPTOMS WITH MINIMAL HOSPITAL STAY. IT CAN BE PERFORMED IN AN OFFICE-BASED SETTING UNDER LOCAL ANESTHESIA, MAXIMIZING UTILIZATION OF THE SURGICAL THEATRE.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE HONG KONG MEDICAL JOURNAL THAT A RETROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE PERIOPERATIVE AND EARLY POSTOPERATIVE OUTCOMES OF TRANSURETHRAL WATER VAPOR THERMAL THERAPY (WVTT) UNDER LOCAL ANESTHESIA ALONE FOR BENIGN PROSTATIC ENLARGEMENT IN CHINESE PATIENTS. A TOTAL OF 50 CHINESE PATIENTS WHO EXHIBITED CLINICAL INDICATIONS (ACUTE RETENTION OF URINE OR SYMPTOMATIC LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC ENLARGEMENT) FOR SURGICAL TREATMENT BETWEEN JUNE 2020 AND DECEMBER 2021 IN HONG KONG WERE INCLUDED. EXCLUSION CRITERIA INCLUDED ACTIVE URINARY TRACT PROBLEMS AND UROLOGICAL MALIGNANCIES. FOLLOW-UP WAS CONDUCTED AT 3 MONTHS POSTOPERATIVELY. THE MEDIAN PATIENT AGE WAS 71.5 YEARS. THE MEAN PREOPERATIVE PROSTATIC VOLUME WAS 56.7 ML. THE MEAN OPERATION TIME WAS 25.1 MINUTES. ALL PROCEDURES WERE PERFORMED UNDER LOCAL ANESTHESIA ALONE. THE MEAN PAIN SCORES FOR TRANSRECTAL ULTRASOUND PROBE INSERTION, TRANSPERINEAL LOCAL ANESTHESIA INJECTION, AND TRANSURETHRAL WVTT WERE 2, 5, AND 4, RESPECTIVELY. FORTY-NINE PATIENTS (98%) WERE DISCHARGED ON THE SAME DAY WITH A URETHRAL CATHETER. FORTY-EIGHT PATIENTS (96%) SUCCESSFULLY COMPLETED A TRIAL WITHOUT CATHETER WITHIN 3 WEEKS POSTOPERATIVELY. FIVE PATIENTS (10%) HAD UNPLANNED HOSPITAL ADMISSION WITHIN 30 DAYS POSTOPERATIVELY DUE TO SURGICAL COMPLICATIONS (CLAVIEN-DINDO GRADE 1). ONLY ONE PATIENT (2%) REQUIRED BLADDER IRRIGATION FOR 5 DAYS POSTOPERATIVELY; THAT PATIENT HAD BEEN TAKING APIXABAN BEFORE SURGERY. TWO PATIENTS (4%) WITH AN INITIALLY UNSUCCESSFUL TWOC BEGAN TEMPORARY CLEAN INTERMITTENT SELF-CATHETERISATION; THEY WERE SUBSEQUENTLY WEANED FROM THIS MANAGEMENT APPROACH ON POSTOPERATIVE DAYS 40 AND 45, RESPECTIVELY. THERE WERE THREE REPORTED CASES (6%) OF NEW-ONSET ERECTILE DYSFUNCTION POSTOPERATIVELY. ALL THREE PATIENTS HAD TEMPORARY ERECTILE DYSFUNCTION THAT RESOLVED WITHIN 6 MONTHS POSTOPERATIVELY WITHOUT REQUIRING MEDICATION. SOME ADDITIONAL ADVERSE EVENTS OBSERVED IN THE STUDY WERE LIGHT HEMATURIA, POST-OBSTRUCTIVE DIURESIS, RECURRENT ACUTE RETENTION OF URINE (AROU) AND URINARY TRACT INFECTION (UTI) WITH AROU. TRANSURETHRAL WVTT, AN ADVANCED SURGICAL TREATMENT FOR BENIGN PROSTATIC ENLARGEMENT, IS A SAFE PROCEDURE THAT RELIEVES LOWER URINARY TRACT SYMPTOMS WITH MINIMAL HOSPITAL STAY. IT CAN BE PERFORMED IN AN OFFICE-BASED SETTING UNDER LOCAL ANESTHESIA, MAXIMIZING UTILIZATION OF THE SURGICAL THEATRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 465899 | REZUM | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |